Delcath Systems Announces $20 Million Private Placement

On July 11, 2019 Delcath Systems, Inc. ("Delcath," the "Company", "we", "our" or "us") (OTCPK: DCTH) reported that it has entered into a definitive agreement for gross proceeds of approximately $20 million at a combined price of $1,000 per Unit (Press release, Delcath Systems, JUL 11, 2019, View Source;p=RssLanding&cat=news&id=2403505 [SID1234537498]). Each Unit consists of one preferred share initially convertible into 16,667 shares of common stock at an initial conversion price of $0.06 per share and a common stock purchase warrant. Each whole warrant entitles the holder to purchase one share of common stock at an initial exercise price of $0.06 for a period of five years from the date of the Company’s anticipated reverse stock split.

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Roth Capital Partners is acting as the sole placement agent for the offering. After the placement agent fees and estimated offering expenses payable by the Company, the Company expects to receive net proceeds of approximately $18.35 million. The offering is expected to close on July 15, 2019, subject to customary closing conditions.

The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended or applicable under state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company has agreed to file a resale registration statement on Form S-1 with the Securities and Exchange Commission by August 21, 2019 for purposes of registering the resale of the shares of common stock issuable upon conversion of the preferred shares and upon exercise of the warrants issued in the private placement.

This notice does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

IDEAYA Biosciences Announces First Patient Dosing of PKC inhibitor IDE196 in Phase 1/2 Tissue-Type Agnostic Basket Trial for Solid Tumors Harboring GNAQ or GNA11 Mutations

On July 11, 2019 IDEAYA Biosciences, Inc., an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported initiation of its Phase 1/2 study evaluating IDE196 in Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions (ClinicalTrials.gov Identifier: NCT03947385) (Press release, Ideaya Biosciences, JUL 11, 2019, View Source [SID1234537497]). The first patient dosing was in June 2019 and clinical trial sites are now enrolling in the U.S. and Australia.

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IDEAYA previously announced that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for the development of IDE196 as a treatment for metastatic uveal melanoma and other solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations. "IDEAYA’s tissue-type agnostic strategy provides a genetic biomarker driven approach to treat patients whose tumors harbor GNAQ or GNA11 hotspot mutations across multiple solid tumors, including uveal melanoma, cutaneous melanoma, and colorectal cancer," said Meredith McKean, MD, MPH, Melanoma and Skin Cancer Research Program, Sarah Cannon Research Institute.

"We are delighted to announce our first patient dosing for IDE196 in our tissue type agnostic GNAQ and GNA11 basket trial, and the opportunity to advance IDE196 in its dose escalation with the goal of enabling the optimal dose selection for the Phase 2 portion of the trial," said Julie Hambleton, M.D., Chief Medical Officer, Head of Development at IDEAYA Biosciences.

IDE196 is a potent small molecule protein kinase C (PKC) inhibitor demonstrating clinical activity and tolerability in a separate ongoing Phase 1 trial of IDE196 in patients with Metastatic Uveal Melanoma (MUM). Approximately 90% of uveal melanoma patients harbor activating mutations in GNAQ or GNA11 (GNAQ/11). Mutations in GNAQ/11 have also been observed in other solid tumors, such as cutaneous melanoma, colorectal, pancreatic, stomach, cervical, lung adenocarcinoma and bladder. The clinical focus of IDEAYA’s Phase 1/2 basket trial will be on treatment of patients having tumors with likely pathogenic GNAQ/11 hotspot mutations, which are known to activate the PKC signaling pathway. GNAQ/11 hotspot mutations are not generally known to overlap with other oncogenic driver mutations, such as BRAF and NRAS mutations, in certain solid tumors.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Nova to Report Second Quarter 2019 Financial Results on August 7, 2019

On July 11, 2019 Nova (Nasdaq: NVMI), reported that it will release its results for the second quarter of 2019 before the Nasdaq market opens on Wednesday, August 7, 2019 (Press release, Nova Medical Group, JUL 11, 2019, View Source [SID1234537496]).

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Mr. Eitan Oppenhaim, President and Chief Executive Officer, and Mr. Dror David, Chief Financial Officer, will host a conference call that same day, August 7, 2019, at 9 a.m. Eastern Time.

To attend the conference call, please dial one of the following teleconferencing numbers. Please begin by placing your call at least five minutes before the conference call commences. If you are unable to connect using the toll-free numbers, please try the international dial-in number.

U.S. TOLL-FREE Dial-in Number: 1-800-289-0438
ISRAEL TOLL-FREE Dial-in Number: 1-809-212-883
INTERNATIONAL Dial-in Number: 1-323-794-2423
At:
9 a.m. Eastern Time
6 a.m. Pacific Time
4 p.m. Israel Time

Conference Call ID: 4935686

The conference call will also be webcast live from a link on Nova’s website at View Source

A replay of the conference call will be available from August 7, 2019 at 12 p.m. Eastern Time to August 14, 2019 at 11:59 p.m. Eastern Time. To access the replay, please dial one of the following numbers:

Replay Dial-in TOLL-FREE: 1-844-512-2921
Replay Dial-in TOLL/INTERNATIONAL: 1-412-317-6671
Replay Pin Number: 4935686

A replay will also be available for 90 days on Nova’s website at View Source

Evogene Financial Results for the Second Quarter of 2019 Earnings Announcement Schedule

On July 11, 2019 Evogene Ltd. (NASDAQ: EVGN), (TASE: EVGN), a leading biotechnology company developing novel products for life science markets, reported that it will release its financial results for the second quarter of 2019 on Wednesday, July 31, 2019 (Press release, Evogene LTD, JUL 11, 2019, View Source [SID1234537495]).

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On the day of the announcement, the Company’s management will host a conference call to discuss the results at 09:00 AM Eastern time, 16:00 Israel time. To access the conference call, please dial 1-888-668-9141 toll free from the United States, or +972-3-918-0609 internationally. Access to the call will also be available via live webcast through the Company’s website at www.evogene.com.

A replay of the conference call will be available approximately three hours following the completion of the call. To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5904 internationally. The replay will be accessible through August 2, 2019, and an archive of the webcast will be available on the Company’s website through August 11, 2019.

Nordic Nanovector Completes Patient Enrolment Into Phase 1 Trial of Betalutin® in Diffuse Large B-cell Lymphoma (DLBCL)

On July 11, 2019 Nordic Nanovector ASA (OSE: NANO) reported that the final patient has been enrolled in the LYMRIT 37-05 clinical trial of Betalutin (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for stem cell transplantation (Press release, Nordic Nanovector, JUL 11, 2019, View Source [SID1234537494]).

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The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study designed to assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of a single administration of Betalutin. Patients were enrolled at clinical trial sites in the US and Europe. More information on this study can be found at www.clinicaltrials.gov (NCT02658968). Preliminary results are expected in the second half of 2019.

DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for up to 43% of all NHL cases, making it the most common form of the disease. Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy and only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by Stem Cell Transplantation (ref. 1 below). There are currently very few therapeutic options for patients not eligible for SCT, which makes relapsed DLBCL a serious unmet medical need. The number of diagnosed cases of DLBCL in the US and Europe in 2016 was 26,500 and 17,200, respectively. These numbers are expected to reach 31,500 (US) and 19,000 (Europe) by 2024 (ref. 2 below).

Lisa Rojkjaer, Chief Medical Officer at Nordic Nanovector, said: "We are delighted to have reached this important milestone and look forward to the preliminary results during the second half of the year. Planning is underway for an expansion cohort to further assess safety and efficacy in this challenging to treat patient population. We expect more patients to be enrolled when the best dose is selected from the first part of the study."

References

1. L.S. Raut and P. P. Chakrabarti: Management of relapsed-refractory diffuse large B cell lymphoma (2014) South Asian J. Cancer 3(1): 66–70

2. Non-Hodgkin’s Lymphoma (2015) Decision Resources